Director, Clinical Operations, Therapeutics and Oncology

Role Summary

Director of Clinical Operations to manage oncology programs which may consist of one or more studies. This is a clinical operations program management role responsible for initiating and leading clinical programs across all phases, including overseeing CROs and vendors, and working cross-functionally on clinical operations strategy and related initiatives. Reports to the Senior Director, Clinical Operations, Therapeutics and Oncology with a focus on oncology.

Responsibilities

• Accountable for delivery of assigned clinical program budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders
• Oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs
• Support the selection, oversight, and management of CROs and other vendors
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna
• Support program level deliverables/activities
• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff.
• Strive for continuous improvement and more efficient ways of working in clinical development
• Act as a role model for Moderna‚Äôs values

Qualifications

• Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management; Advanced degree preferred.
• Robust experience in oncology required. Late-stage/phase 3 experience required. Experience in immuno-oncology is desirable but not required.
• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Experience in GCP inspections/audits
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
• Resilient, Creative, capable problem-solver
• Excellent organizational skills and ability to work independently
• Experience in establishing and maintaining relationships with key opinion leaders
• Some travel required

Skills

• Operational strategy and clinical operations planning
• Vendor/CRO management and oversight
• ICH/GCP compliance and regulatory knowledge
• Cross-functional collaboration and stakeholder management
• Study budgeting, timelines, and resource management
• Leadership and mentorship

Education

• BA/BS required; advanced degree preferred.